Associate Director, Clinical Operations

About the role

The Associate Director of Clinical Operations at Bamboohr will play a pivotal role in overseeing and enhancing clinical trial processes within the organization. This position requires a strategic leader who is adept at managing clinical operations, ensuring compliance with regulatory standards, and driving the successful execution of clinical studies. The ideal candidate will collaborate closely with cross-functional teams to streamline operations and improve overall efficiency while maintaining a focus on patient safety and data integrity.

Key facts

What you'll do

• Lead and manage clinical operations for multiple clinical trials, ensuring adherence to timelines, budgets, and regulatory requirements.
• Develop and implement operational strategies that align with the company's goals and objectives, enhancing the efficiency of clinical trial processes.
• Collaborate with clinical project managers and cross-functional teams to ensure seamless execution of clinical studies from initiation to completion.
• Oversee the selection and management of clinical research sites, ensuring that they meet the necessary standards for conducting clinical trials.
• Monitor trial progress and performance metrics, identifying areas for improvement and implementing corrective actions as needed.
• Ensure compliance with Good Clinical Practice (GCP) and other regulatory guidelines throughout the clinical trial lifecycle.
• Prepare and present operational updates to senior management, highlighting key milestones, challenges, and opportunities for improvement.
• Foster a culture of continuous improvement within the clinical operations team, encouraging innovative approaches to enhance trial efficiency and quality.
• Manage and mentor clinical operations staff, providing guidance and support to promote professional development and team cohesion.
• Collaborate with external stakeholders, including regulatory agencies and clinical research organizations, to facilitate successful trial execution.
• Develop and oversee budgets for clinical trials, ensuring effective resource allocation and financial management.
• Stay current with industry trends and advancements in clinical operations to inform best practices and strategic planning.

Requirements

• Bachelor's degree in life sciences, nursing, or a related field; advanced degree preferred.
• A minimum of 8 years of experience in clinical operations, with at least 3 years in a leadership role.
• Proven track record of managing clinical trials from initiation to completion, with a strong understanding of regulatory requirements.
• Excellent organizational and project management skills, with the ability to prioritize and manage multiple projects simultaneously.
• Strong analytical and problem-solving abilities, with a keen attention to detail.
• Exceptional communication and interpersonal skills, capable of building relationships with diverse stakeholders.
• Experience with budget management and resource allocation in a clinical trial setting.
• Proficiency in clinical trial management systems and electronic data capture tools.
• Ability to work collaboratively in a fast-paced, dynamic environment.

Nice to have

• Experience in a biotech or pharmaceutical company, particularly in the areas of oncology or rare diseases.
• Familiarity with electronic health records (EHR) and other healthcare technologies.
• Previous experience in vendor management and oversight of contract research organizations (CROs).
• Certification in clinical research (e.g., ACRP or SOCRA) is a plus.
• Knowledge of international clinical trial regulations and guidelines.

Skills & tools

• Strong leadership and team management skills.
• Proficient in Microsoft Office Suite (Excel, Word, PowerPoint) and project management software.
• Familiarity with statistical analysis software and data visualization tools.
• Understanding of clinical trial design and methodology.
• Ability to analyze complex data sets and generate actionable insights.

Practical notes

• This role is based in South San Francisco, California, and may require occasional travel to clinical sites or conferences.
• The salary for this position will be competitive and commensurate with experience.
• Bamboohr is committed to fostering a diverse and inclusive workplace, and we encourage applications from candidates of all backgrounds.
• Candidates must be eligible to work in the United States; visa sponsorship is not available for this position.

META

Company: Bamboohr

Title: Associate Director, Clinical Operations

Listed

location: South San Francisco, California

Job type: Full-Time Employment

Apply URL: https://structuretx.bamboohr.com/careers/507

Tags: Operations, Director